Reliability and Process Engineering Specialist
PharmaBiotechRegulatory AffairsQuality Assurancegmpcroinform
Job description
R2869291 Reliability and Process Engineering Specialist Location: Toronto, ON About the job Join a global network that powers how Sanofi delivers — seamlessly, purposefully, and at scale. In Manufacturing & Supply, you’ll help reimagine how life-changing treatments reach people everywhere, faster. The Engineering and Maintenance (E&M) Reliability and Methods Department operates within the Reliability and Support Department of the broader Engineering and Maintenance organization. The Reliability and Methods Department is responsible for: Equipment Reliability – Ensuring manufacturing equipment operates at peak performance and availability Process Engineering – Optimizing production processes for efficiency and consistency Preventive Maintenance – Implementing strategies to minimize downtime and extend equipment life Spare Parts Management – Managing inventory and MRO (Maintenance, Repair, Operations) resources Methods Development – Establishing best practices and standardized approaches to reliability engineering. About Sanofi We’re an R&D-driven, AI-powered biopharma company committed to improving people’s lives and delivering compelling growth. Our deep understanding of the immune system – and innovative pipeline – enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve people’s lives. Main Responsibilities: Overall plant reliability (equipment, utilities, and facilities) Monitoring of M&R value, performance, and cost effectiveness Maintenance strategy and continuous optimization Reliability technology (PdM, data analytics, digital WO) Spare parts inventory optimization (criticality, stocking, FE) Additional Responsibilities: Perform Parts Inventory Optimization (Criticality/Stocking) Create and Optimize Preventative maintenance Tasks Lists. Assess risks related to missed PMs and support exception management. Review and approve Engineering/Vendor Turnover packages. Monitor and improve M&R value through KPIs and RCM tools (FMEA, RCA, SPC). Drive continuous improvement and failure elimination initiatives across E&M platforms. Maintain and execute long-term asset plans, manage equipment registration, and support CAPA development. Ensure technical governance and audit readiness, including regulatory inspection support and GMP compliance. Participate in risk assessments, deviation review boards, and GMP documentation updates. Perform investigations for deviations and maintenance issues, ensuring timely, thorough root cause analysis and reporting Apply RCM tools (RCA, FMEA, SPC) and collaborate with cross-functional teams to implement preventative actions. Participate in CAPA planning and DRB meetings for timely investigation closures. Collaborate with Manufacturing, Quality Operations, and SMEs to ensure investigation timelines are met. Support cross-functional teams in GMP documentation About You Bachelor's degree in engineering with 5 years of relevant experience in manufacturing, maintenance, or engineering environments. At least 1 year working with internal and contracted maintenance personnel in pharma or related industry. Experience in regulatory inspections and GMP environments. Strong investigation and problem-solving skills. Excellent communication, organization, and technical writing abilities. Six Sigma or equivalent root cause analysis training is preferred. Familiarity with CMMS systems and reliability tools (RCM, FMEA, RCA, SPC). Knowledge of cGMPs and pharmaceutical/biological manufacturing standards. In-depth knowledge of predictive technologies is preferred. Why Choose Us? Bring the miracles of science to life alongside a supportive, future-focused team. Discover endless opportunities to grow your talent and drive your career, whether it’s through a promotion or lateral move, at home or internationally. Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact. Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs. This position is for a new vacant role that is now open for applications. AI Usage "Artificial Intelligence” refers to any systems that use automated processes, including algorithms and machine learning, to analyze data and make predictions, inferences, decisions, or recommendations without direct human involvement. These systems may process personal information to identify patterns, improve services, or support decision-making. The Company may use Artificial Intelligence for purposes including, but not limited to, resume screening and hiring, scheduling interviews or meetings, conducting surveys, matching skills with potential job openings, interview scoring, ensuring compliance with regulations applicable to our industry, and activities related to performance evaluation. Information collected and processed by the Company’s Artificial Intelligence systems may include the personal information detailed above and calendar availability. It excludes the information collected and processed for monitoring purposes. You should contact Human Resources if you have a question or concern regarding your personal information. You can also contact Canada’s Privacy Officer via Sanofi’s data subject request portal, Data Subject Rights Webform . The Data Subject Rights Webform can also be used to request access or correction of your personal information and file a complaint. Sanofi is an equal opportunity employer committed to diversity and inclusion. Our goal is to attract, develop and retain highly talented employees from diverse backgrounds, allowing us to benefit from a wide variety of experiences and perspectives. We welcome and encourage applications from all qualified applicants. Accommodations for persons with disabilities required during the recruitment process are available upon request. #GD-SP #LI-SP #LI-Onsite Pursue progress , discover ext
Stand out for this role
NoxPharm tailors your CV to this job description by aligning your experience with the role requirements and terminology. Built for pharma & life sciences.
Tailor my CV now — free to trySimilar Pharma jobs
Associate, Project Management (Pharmaceutical Labeling)
Open Scientific — Hauppauge, us
Maintenance Coordinator
Open Scientific — Bohemia, us
Manufacturing Operators - Pharmaceutical
Open Scientific — Melville, us
Pharmaceutical Mechanics - Packaging, Production, Maintanence
Open Scientific — Hauppauge, us
Warehouse - Pharmaceutical
Open Scientific — Hauppauge, us
Pharmaceutical Machine Operators
Open Scientific — Hauppauge, us